This year marks three decades since the 1988 Surgeon General’s report, The Health Consequences of Smoking: Nicotine Addiction, shattered the myth of smoking as a “bad habit.” Surgeon General C. Everett Koop’s report of 30 years ago—one in a series that began in 1964 to warn about smoking’s health hazards—presented the science showing that cigarettes are addictive because of the nicotine they deliver. The report provided scientific elaboration about an addiction doctors were witnessing firsthand, as patients struggled without success to quit smoking and often died after arduous battles with lung cancer, heart disease, or another smoking-related illness.

Like the 1988 Surgeon General’s report, FDA’s comprehensive plan for tobacco and nicotine regulation, announced last July, focuses on nicotine and the issue of addiction. The new plan recognizes not only that nicotine creates and sustains addiction to tobacco products, but also that the way a product delivers nicotine is more directly linked with the dangers a product presents. The agency is focused on improving health and saving lives by moving people away from tobacco products that cause the most harm, while encouraging industry innovation in potentially less harmful products that could provide nicotine for adults who still seek it. With cigarettes known to be among the most harmful tobacco products, the agency is considering a product standard that would set a maximum level of nicotine in cigarettes, rendering them minimally or nonaddictive. (Stay tuned! Learn more in an upcoming issue of CTP Connect.)

The new plan addresses a landscape of tobacco products that has evolved vastly since the 1980s, and FDA’s current tobacco regulatory decision-making benefits from decades of additional research that has continually and immensely advanced our scientific understanding. “Today, we have the tools, the resolve, and the modern, multifaceted regulatory plan that together can advance us toward a definitive win in the battle against tobacco’s deadly consequences,” summed up FDA Commissioner Scott Gottlieb, M.D.

In this issue of CTP Connect, learn about some steps FDA is taking—relying on robust science, public education, and an ongoing public dialogue—to identify the most effective approaches to tobacco regulation.

It’s common knowledge that cigarette smoking is deadly, so why do people continue to smoke? A primary reason is, in a word, addiction. Under the new tobacco regulatory framework, the stage is set not only for reducing addiction to cigarettes by reducing the nicotine in them, but also for encouraging innovation in development of potentially less harmful tobacco products for adults who seek them.

With a recent extension of application deadlines for many newly regulated tobacco products, FDA has time to develop and establish rules and policies for making tobacco products less toxic, less appealing, and less addictive, as well as foundational rules for overseeing those products. And manufacturers have more time to prepare higher-quality applications.

Meanwhile, the agency is also bringing a new perspective to drug products for smoking cessation, committing to work with sponsors of nicotine replacement therapies—as well as any other products that could help more smokers quit—to bring appropriate innovative products to the marketplace.

Obtaining Public Input on Nicotine Replacement Therapies: Nicotine Steering Committee, Public Hearing, Public Docket for Comments

FDA supports the development of new, more effective therapeutic nicotine products for combustible tobacco product cessation, especially as the agency considers the possibility of steeply reducing permissible levels of nicotine in cigarettes.

Nicotine replacement therapies, which include over-the-counter therapies in forms such as the gum, lozenge, and patch, are designed to help smokers quit by supplying controlled amounts of nicotine to ease withdrawal symptoms. These therapeutic nicotine products can help people quit smoking who can’t cut themselves off immediately and entirely from nicotine.

As a step toward maximizing these products’ therapeutic potential, FDA formed a Nicotine Steering Committee, which includes leaders from across the agency. The committee’s focus is on nicotine policy and regulation, and on the use of therapeutic nicotine for combustible tobacco product cessation, in particular.

The formation of the Nicotine Steering Committee reflects the need to critically examine the evolving science behind FDA’s evaluation of the safety and efficacy of nicotine replacement therapies. By holding a recent public hearing to obtain input on these products and discuss the agency’s approach for evaluating them, the committee has already begun to examine pivotal issues, such as the way therapeutic nicotine products are used and labeled as well as the types of safety and efficacy studies FDA should require.

To receive suggestions, recommendations, and comments on topics or policy issues for the committee’s consideration, FDA has established a public docket. Feedback from interested parties will help the agency identify and address priorities related to the use of these therapeutic cessation products. Additional information about this public docket is available in a Federal Register notice, “Nicotine Steering Committee; Establishment of a Public Docket; Request for Comments.”

“Every time you put out a cigarette is a chance to try quitting again.”
“You didn’t fail at quitting. You just haven’t finished the process.”

These supportive messages are among those that make up CTP’s “Every Try Counts” public education campaign, which celebrates each quit attempt and encourages adults who have tried unsuccessfully to quit smoking to make another attempt.

In dozens of counties across the United States where smoking is prevalent, people could see “Every Try Counts” messages at their gas station or convenience store—locations where more than 80 percent of cigarettes are sold and where cigarette advertising and other triggers for purchasing cigarettes are common. In addition, these supportive messages will appear on the radio and online.

Unlike CTP’s other public education campaigns—“The Real Cost,” “Fresh Empire,” and “This Free Life,” which were designed to reach youth and young adults—“Every Try Counts” targets its messages to smokers 25 to 54 years of age. Adults who have tried unsuccessfully to quit are far from alone. According to a recent study, about two-thirds of adult smokers say they want to quit. Of the 55 percent who attempted to quit in a recent year, only 7 percent succeeded.

For more information—on how you can help spread the word about the campaign, for example, and whether print versions of campaign materials are available for use in your area—visit our “Every Try Counts Campaign" webpage.

At a meeting on Jan. 24–25, the Tobacco Products Scientific Advisory Committee (TPSAC) discussed issues related to modified risk tobacco product (MRTP) applications submitted by Philip Morris Products S.A. for its iQOS system and several Marlboro Heatsticks products, which are currently under review by FDA. The applicant describes its iQOS system as a “heat-not-burn” product.

MRTPs are tobacco products sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. FDA can issue an order authorizing marketing of an MRTP only if the evidence submitted in an application meets certain requirements. For example, an MRTP application must demonstrate that the product will, or is expected to, benefit the health of the population as a whole. TPSAC provides advice to FDA on issues and questions referred to the committee by the agency about MRTP applications submitted by a manufacturer.

To learn more and access information made available by FDA to aid in the committee’s evaluation—including briefing materials, public submissions, and presentations—or to view a recorded webcast of the meeting, please visit CTP’s 2018 TPSAC Meeting Materials and Information webpage.

E-Cigarettes’ Public Health Impact: Findings of the National Academies

A report titled Public Health Consequences of E-Cigarettes was released on Jan. 23 by the National Academies of Sciences, Engineering, and Medicine (NASEM). The report adds to FDA’s knowledge base on e-cigarettes and other electronic nicotine delivery systems (ENDS), while raising some important questions about the public health impact of e-cigarettes.

The independent report, commissioned by FDA at the request of Congress, evaluated scientific evidence about the health effects linked to the use of e-cigarettes and other ENDS. According to the report, evidence suggests that current smokers who completely switch to e-cigarettes may see improved short-term health outcomes. Meanwhile, in a finding FDA Commissioner Scott Gottlieb, M.D., characterized as “particularly troubling,” the report also found that kids and young adults who use e-cigarettes are more likely to try smoking cigarettes.

The report calls for additional research on e-cigarettes’ short- and long-term health effects, as well as their impact on public health. The recommended research should consider factors such as whether these products are leading to youth initiation of cigarettes, resulting in adult dual use with cigarettes, or helping accelerate the transition of current adult smokers entirely away from combustible cigarettes. The report notes that the wide diversity of ENDS products presents a challenge for researchers.

“We appreciate the National Academies’ review of the complex public health considerations around e-cigarettes,” said FDA Commissioner Gottlieb. As the agency works to reduce tobacco-related disease and death and protect kids from tobacco products, the report “helps identify areas that need further study to better understand the net public health impact of e-cigarettes,” he stated.

FDA continues to invest in many of the areas of research identified in the National Academies report to assess whether certain tobacco products are, in fact, less harmful and whether they have potential as a tool to help smokers transition completely away from combustible cigarettes. “We need to put novel products like e-cigarettes through an appropriate series of regulatory gates,” Commissioner Gottlieb emphasized, “to fully evaluate their risks and maximize their potential benefits.”